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Metabolomic Study of All-age Cardiomyopathy (MAC)

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ClinicalTrials.gov Identifier: NCT03061994
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Institute of Heart, Lung and Blood Vessel Diseases

Brief Summary:
This study aims to 1)characterize the differentially expressed metabolites between cardiomyopathy patients and healthy controls,2)identify the specific biomarkers associated with outcomes or risk evaluation in patients with different cardiomyopathies in a follow-up of a cohort and 3)to determine whether differentially expressed may affect the pathological process of cardiomyopathies . Standardized protocols will be used for the assessment of medical history and examinations, laboratory biomarkers, and the collection of blood plasma.

Condition or disease
Dilated Cardiomyopathy Hypertrophic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy Left Ventricular Non-compaction Restrictive Cardiomyopathy

Detailed Description:
The aim of this study is to analyze metabolomic profile of patients with cardiomyopathy in order to identify biochemical markers with risk stratification and prognostic value. Clinical data of enrolled patients regarding demographics, cardiovascular risk factors,clinical lab data and previous cardiovascular disease will be recorded. Follow up will be at 3 months,6 months,9 months,1 year and 3 years and will be performed by clinical recordings or phone call when necessary. Blood samples of patients with cardiomyopathy are taken when they enrolled. Serum samples will be analyzed by Liquid Chromatograph Mass Spectrometer/Mass Spectrometer.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Metabolomic Study of Patients With Cardiomyopathy in China
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020


Group/Cohort
Cardiomyopathy

Children(older than 18 years old) are diagnosed as cardiomyopathy by three cardiologists and recruited in pediatric heart center,Beijing Anzhen Hospital, recording the results of clinical lab and echocardiography.

Adults are diagnosed as cardiomyopathy by three cardiologists and recruited in the department of cardiology ,Beijing Anzhen Hospital.

Control
Healthy children and adults are recruited in Beijing Anzhen Hospital, with negative results of echocardiography and clinical lab examination.



Primary Outcome Measures :
  1. Result of echocardiography [ Time Frame: three year ]
    The whole results of echocardiography report will be recorded. The indicates whi ch can reflect cardiac function including Left ventricular ejection fraction, left ventricular end diastolic diameter, E/A ratio of bicuspid valve will be used to calculate the association with metabolites.


Secondary Outcome Measures :
  1. Cardiovascular death [ Time Frame: One year/Three year ]
    The data is collected during follow-up visit at 1/3 years after discharge

  2. Re-hospitalization [ Time Frame: One year/Three year ]
    patients are hospitalized due to heart failure with decreasing left ventricular ejection fraction (LVEF) or worsen symptoms. The data is collected during follow-up visit at 1/3 years after discharge

  3. Heart transplantation [ Time Frame: One year/Three year ]
    patients are hospitalized due to heart failure.The data is collected during follow-up visit at 1/3 years after discharge

  4. malignant arrythmia [ Time Frame: One year/Three year ]
    Ventricular flutter and fibrillation, atrioventricular block,atrial fibrillation or other cardiac arrhythmia leads to syncope or should be Implantable Cardioverter-Defibrillator (ICD) implantation.

  5. Worsening heart failure [ Time Frame: These data is collected from the cases' medical record in an average of 1/3/6/9/12/36 months after the sample recruiting ]
    Worsen heart failure is defined as decreased ejection fraction(left ventricular ejection fraction decreased over 10%), left ventricular ejection fraction <45% and enlarged heart size measured by echocardiography and changing level of New York Heart Association (NYHA) Functional Classification.And patients who undergo left ventricular assist device (LVAD) will also be included.The data is collected during follow-up visit at 3/6/9/12/36 months after enrollment.

  6. Metabolomic profile on Liquid Chromatograph Mass Spectrometer/Mass Spectrometer analysis of plasma sample [ Time Frame: The data is collected from lab in an average of 3 month after the sample recruiting ]
    The results of metabolomics will be measured by mass spectrometry, including lipids, sugars and amino acids. All of metabolites will be quantitative(unit:mol/L). Identification of molecules via Human Metabolites Database will be reported online.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A diagnosis of cardiomyopaty is adjudicated by three cardiologists,according to current guidelines when there was clinical evidence of cardiomyopathy together with clinical symptoms of heart failure or echocardiography or imaging evidence.

age- and gender- mathced healthy controls are also recuitted in the hospital.

Criteria

Inclusion Criteria:

  1. Subjects who was diagnosed as cardiomyopathy by medical history, clinical symptoms, laboratory tests including ECG, echocardiography.
  2. Subject understands study requirements aand agrees to sign an informed consent form prior to any study procedures

Exclusion Criteria:

  1. Endocrine disease known to cause heart muscle disease (including infants of diabetic mothers)
  2. History of rheumatic fever
  3. Toxic exposures known to cause heart muscle disease (anthracyclines, mediastinal radiation, iron overload or heavy metal exposure)
  4. HIV infection or born to an HIV positive mother
  5. Kawasaki disease
  6. Immunologic disease
  7. Uremia, active or chronic
  8. Abnormal ventricular size or function that can be attributed to intense 9.physical training or chronic anemia

10.Chronic arrhythmia, unless there are studies documenting inclusion criteria prior to the onset of arrhythmia (except a patient with chronic arrhythmia, subsequently ablated, whose cardiomyopathy persists after two months is not to be excluded) 11.Malignancy 12.Pulmonary parenchymal or vascular disease (e.g., cystic fibrosis, cor pulmonale, or pulmonary hypertension) 13.Ischemic coronary vascular disease 14.Association with drugs (e.g., growth hormone, corticosteroids, cocaine) or other diseases known to cause hypertrophy


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03061994


Contacts
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Contact: Jie Du, PhD jiedubj@126.com
Contact: Hongzhao You hongzhao_you@163.com

Locations
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China, Beijing
Beijing Institute of heart, lung and blood vessel diseases Recruiting
Beijing, Beijing, China
Contact: Jie Du, PhD       jiedubj@126.com   
Contact: Yulin Li, PhD       lyllyl_1111@163.com   
Sub-Investigator: Hongzhao You         
Sponsors and Collaborators
Beijing Institute of Heart, Lung and Blood Vessel Diseases
Investigators
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Study Director: Yulin Li, PhD Beijing anzhen hospital affiliated to capital medical university
Study Director: Yongqiang Lai, MD Beijing anzhen hospital affiliated to capital medical university

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Responsible Party: Beijing Institute of Heart, Lung and Blood Vessel Diseases
ClinicalTrials.gov Identifier: NCT03061994     History of Changes
Other Study ID Numbers: BeijingIHLBVD2016023
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cardiomyopathies
Cardiomyopathy, Hypertrophic
Cardiomyopathy, Dilated
Arrhythmogenic Right Ventricular Dysplasia
Cardiomyopathy, Restrictive
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Cardiomegaly
Heart Defects, Congenital
Cardiovascular Abnormalities
Congenital Abnormalities